FDA lets KRAS gene narrow drug use

Personalized cancer treatment took a giant step forward today. FDA has OK'd a label change for Erbitux and Vectibix, narrowing the indication for advanced colon cancer. The label now recommends the drugs as a treatment for EGFR-expressing tumors only in patients without KRAS gene mutations.

Believe it or not, the drugmakers asked for the restricted use [1]. In fact, Amgen, ImClone/Eli Lilly and Bristol-Myers Squibb have been lobbying for it. That's because the drugs work well in patients without the KRAS mutations and don't work well at all in those with the mutated gene form. That brings effectiveness stats down when the drugs are broadly used--and as pricey as these meds are, the drugmakers want customers to get their money's worth. Otherwise, insurers and other payers may not want to foot the bill.

"We are pleased that the FDA has recognized the clinical importance of KRAS as a predictive biomarker for anti-EGFr antibody therapy," Dr. Sean Harper, Amgen's chief medical officer and head of global development, said in a statement. The FDA's decision follows an advisory committee meeting some months ago, where Amgen was among those arguing for the change. And in January, the American Society of Clinical Oncology recommended that patients with mutant KRAS shouldn't get this type of meds. 

- read the release from ImClone and Bristol
[2]- get Amgen's statement
[3]- check out the WSJ Health Blog piece [4]

Related Articles:
ASCO: Narrow use of Erbitux, Vectibix [5]
Amgen asks FDA to narrow Vectibix use [1]
FDA advisers skeptical of retrospective genetic analysis [6]
J&J researchers on the future of personalized medicine [7]
Personalized medicine comes into its own [8]